Reasoned opinion on the modification of the existing MRLs for abamectin in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(7):4189 [27 pp.].
doi
10.2903/j.efsa.2015.4189
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013-00740
Approved
2 July 2015
Published
16 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Crop Protection AG to modify the existing maximum residue levels (MRLs) for abamectin in various crops. The EMS proposed to raise the existing MRLs in all crops, except scarole. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. EFSA concludes on MRL proposals of 0.02 mg/kg on pome fruits, 0.04 mg/kg on cucurbits with edible peel and 0.05 mg/kg on Chinese cabbage and celery. For beans and peas with pods, an amendment of the MRL of 0.03 mg/kg proposed under the Article 12 review is not necessary. No MRL can be proposed for the intended uses on the groups of lettuces and other salad plants and spinaches and similar leaves. Enforcement methods are available, however none of them is sufficiently validated and the proposed MRLs should be associated with the submission of the data as requested under the Article 12 MRL review. EFSA concludes that the residues of abamectin resulting from the intended uses on pome fruits, cucurbits with edible peel, Chinese cabbage, beans and peas with pods and celery will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern. However, the risk assessment is indicative pending the submission of the confirmatory data requested under the Article 12 MRL review

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Crop Protection AG to modify the existing maximum residue levels (MRLs) for abamectin in various crops. The EMS proposed to raise the existing MRLs in all crops, except scarole. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 30 August 2013.

EFSA bases its assessment on: the evaluation report and additional information submitted by the EMS at EFSA’s request; the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC; the conclusion on the peer review of the pesticide risk assessment of the active substance abamectin; the JMPR reports; and the conclusions from previous EFSA reasoned opinions on abamectin.

The toxicological profile of abamectin was investigated under the peer review and the data were sufficient to conclude on an acceptable daily intake (ADI) value of 0.0025 mg/kg bw per day and an acute reference dose (ARfD) value of 0.005 mg/kg bw.

  1. The metabolism of abamectin in plants was investigated in three crop groups following foliar applications. The review of the existing MRLs for abamectin performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue definition for enforcement and risk assessment in all plant commodities is the sum of avermectin B1a, avermectin B1b and δ-8,9 isomer of avermectin B1a, expressed as avermectin B1a. For the uses on the crops under consideration, EFSA concludes that the metabolism of abamectin in primary crops is sufficiently addressed and that the residue definitions are applicable.
  2. Since several uses of abamectin proposed in the evaluation report were already evaluated under the Article 12 MRL review, EFSA has not re-assessed them. EFSA concludes on MRL proposals of 0.02 mg/kg on pome fruits, 0.04 mg/kg on cucurbits with edible peel and 0.05 mg/kg on Chinese cabbage and celery. For beans and peas with pods, an amendment of the MRL of 0.03 mg/kg proposed under the Article 12 review is not necessary. No MRL can be proposed for the intended uses on the groups of lettuces and other salad plants and spinaches and similar leaves. Enforcement methods are available, however none of them is sufficiently validated and the proposed MRLs should be associated with the submission of the data as requested under the Article 12 MRL review.

Studies on residues of abamectin in processed commodities are not required as residue levels in the raw agricultural commodities (RAC) are not significant.

Due to the rapid degradation of abamectin in soil, residues in rotational crops were not investigated as no accumulation is expected in soil.

The animal dietary burdens calculated during the Article 12 MRL review are still valid and therefore, the MRLs for products of animal origin proposed during the Article 12 MRL review are applicable.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the chronic consumer risk assessment conducted under the Article 12 MRL review taking into account the median residue levels (STMR) derived from the residue trials on apples, pears, cucumbers, Chinese cabbage, beans and celery. Under the assumption that the MRLs will be amended as proposed during the Article 12 review, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for 9 % of the ADI (German child). No acute consumer intake concerns were identified with regard to the MRL proposals.

EFSA concludes that the residues of abamectin resulting from the intended uses on pome fruits, cucurbits with edible peel, Chinese cabbage, beans and peas with pods and celery will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern. However, the risk assessment is indicative pending the submission of the confirmatory data requested under the Article 12 MRL review.

Keywords
abamectin, various crops, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, insecticide and acaricide
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Number of Pages
27